SRP Proposal G26
SRP Proposal G26
SRP Proposal G26
(UniKL RCMP)
PRINCIPAL RESEARCHER
CO PRINCIPAL RESEARCHER
RESEARCHERS
A.P. DATO’ DR. JEYASEELAN A/L P. NACHIAPPAN, UniKL RCMP & PROF. DR. ABDUL KARIM
RUSS HASSAN, UniKL RCMP & MADAM MASITAH BINTI ISMAIL, UniKL RCMP & DR. CHEW ENG
LAI, HOSPITAL RAJA PERMAISURI BAINUN PERAK & DR. HAEMA SHUNMUGARAJOO,
HOSPITAL RAJA PERMAISURI BAINUN PERAK & VAISHNEVI R SUNDARAM, UniKL RCMP &
HANISSA BT ZAHIDI, UniKL RCMP & AMIRA FARZANA BT MOHAMED ZAINI, UniKL RCMP &
INTAN AZUREEN BT HAMRAN, UniKL RCMP & NUR MAISARAH BT NOORZAID, UniKL RCMP
1. Introduction 3
1.1. Background of Research Problem 3
1.2. Problem Statement 5
1.3. Research Questions 6
1.4. Rationale or Significance of Study 6
1.5. Research Objectives and Hypothesis 6
1.5.1. General Objective 6
1.5.2. Specific Objectives 7
1.5.3. Null Hypothesis 7
2. Literature Review 8
3. Material and Method 11
3.1. Overview of the Study 11
3.2. Study Design 11
3.3. Study and Target Population 11
3.4. Sample Size, Sampling Method and Sampling Frame 12
3.5. Inclusion and Exclusion Criteria 12
3.6. Variables Definition 14
3.7. Method of Data Collection and Technique 16
3.8. Ethical Consideration 23
3.9. Data Management 23
4. Publication Policy 24
4.1 Plan of Data Entry and Analysis 24
5 Work Plan and Budget 26
6 Results 31
7 References 35
8 Appendices 38
8.1 Appendix A 38
8.2 Appendix B 42
8.3 Appendix C 43
8.4 Appendix D 45
1
8.5 Appendix E 46
2
1. Introduction
It is estimated that, at any one time, more than 1.4 million people worldwide are suffering from
infections occur worldwide and affect both developed and developing countries. Infections are
considered nosocomial when they become clinically evident during hospitalisation. Many
pathogens can be transmitted on the hands, which is a major reason that all healthcare workers
must wash their hands before and after seeing each patient.
thermometers, blood pressure cuffs, latex gloves, masks, neckties, pens, badges and lanyards, and
white coats. Fomites carry many bacteria and are responsible for hospital acquired infections. 3
Stethoscopes have been reported to be potential vectors for nosocomial infections in various parts
of the world.4 Even though stethoscopes may harbour regular skin flora such as coagulase-negative
staphylococci, they may also harbour pathogens. Following contact with infected skin, pathogens
such as antibiotic resistant microorganisms can attach and establish themselves on the diaphragms
of stethoscopes, thus can subsequently be transferred to other patients if the stethoscope is not
disinfected.
The use of 70% isopropyl alcohol is found to be more effective in reducing contamination of
3
The aim of the present study is to determine current stethoscope hygiene habits among medical
students and correlate this with a number of factors likely to influence cleaning frequency. From
this, it is hoped that factors inhibiting stethoscope cleaning can be identified and used for future
4
1.2. Problem Statement
institutions have dedicated significant resources to improving compliance with hand-hygiene and
have developed rigorous protocols for the prevention of catheter-associated infections or surgical
site interventions. In contrast, stethoscope cleaning has received relatively little attention, despite
its frequent use in clinical practice.6 In our research, we sought to characterise healthcare workers’
beliefs and practices related to stethoscope cleaning within a clinical or educational setting.
To combat this, daily cleaning of stethoscopes has been shown to reduce the microbial load but
most of the time, stethoscopes are rarely disinfected by healthcare providers. Studies have shown
that medical students might not be committed to the routine cleaning process of the stethoscope
diaphragm even though it could decrease the bacterial load7. It occurs mainly when medical
This low prevalence of stethoscope disinfection could usually be a result of a lack of readily
available equipment or supplies for disinfection. Other possible explanations include lack of time,
the difficulty of the task and the absence of a clear reminder to clean the stethoscope. Hence,
Furthermore, there is no standardised practice in cleaning stethoscopes between patients but there
is a standard guideline in cleaning stethoscopes such as wiping your stethoscopes with 70%
5
isopropyl alcohol solution and not to use hand sanitizer as a cleaning agent as there are additives
Hence, our study is to determine the most effective cleaning method and cleaning agents to reduce
II. Does the cleaning method using 70% isopropyl alcohol significantly reduce the microbial
load?
Cleaning stethoscopes with alcohol swab containing 70% isopropyl alcohol reduces the microbial
6
1.5.2. Specific Objectives
RCMP.
● There is no reduction in the microbial load on the diaphragm of the stethoscopes after
● There is no reduction in the microbial load resulting from the use of various stethoscope
cleaning methods.
7
2. Literature Review
as an infection occurring in a patient in a hospital or other healthcare facility, in whom the infection
was not present or incubating at the time of admission.9 HCAIs are caused by bacteria, fungi or
viruses through various sources including person-to-person contact via the hands of healthcare
and colonised hospital staff.10 A survey conducted by the WHO in 55 hospitals across 14 countries
A stethoscope, as the universal tool of the medical profession, is frequently used for the
cardiopulmonary assessment of the patient. It is used by medical practitioners, students, and health
workers. Therefore, it has been recognised as a potential vector for bacterial transmission because
it is used in direct contact with different kinds of patients daily. 13 A contaminated stethoscope
diaphragm can potentially transmit pathogenic organisms from one patient to another because the
auscultation procedure involves several minutes of contact with the patients’ intact skin, which
provides enough opportunities for pathogen transfer.14 Thus, the stethoscope can be considered as
However, stethoscope cleaning has received relatively little attention, despite its frequent
use in clinical practice. A survey regarding stethoscope cleaning frequency was done by Bansal
and his co-workers of 62 healthcare personnels. The results showed that six individuals cleaned
their stethoscopes less than once a week, six cleaned their stethoscopes every 1 to 4 weeks, two
cleaned their stethoscopes every 5 to 8 weeks, and 15 cleaned their stethoscopes after more than 8
8
weeks. The majority of healthcare providers who responded, 33 (53.22%), had never cleaned their
stethoscopes. Most notably, none of them would clean their stethoscopes after examining each
patient.12
A study done by Muniz et al found that 76% of 3208 healthcare providers at the Children’s
Hospital Boston acknowledged that infection transmission might occur via a stethoscope.
However, only 769 (24%) of them cleaned their stethoscopes after each usage. There are many
reasons behind the low prevalence of stethoscope disinfection, which include a lack of readily
available equipment or supplies for disinfection, a lack of time, the difficulty of the task, and the
Since the original finding of stethoscopes contaminated with staphylococci, there are
actually a lot more potential pathogenic organisms discovered on the stethoscope diaphragm
College and Hospital, the largest microorganism colony found on a stethoscope diaphragm was of
coli, Klebsiella species, Enterococci species, Acinetobacter species, and Candida albicans.18
The evidence suggests that 70% isopropyl alcohol is partially effective in stethoscope
disinfection19. Another study into several kinds of disinfectants have shown the efficiency of
alcohol-based cleaners. The effectiveness of antiseptic soap, ethyl alcohol, and propyl alcohol was
investigated. The pollution of the membranes was reduced by cleaning with three different
9
disinfectants; however, the antiseptic soap was the least effective and the disinfectant based on
Another study found that alcohol wipes were superior to alcohol-based hand rubs for single
The Centres for Disease Control and Prevention (CDC) recommends cleaning stethoscope
surfaces with a disinfectant to reduce antimicrobial action and stop the transmission of healthcare-
associated infections. A stethoscope should also be disassembled, the diaphragms removed from
the chest piece, all surfaces cleaned with a 70% isopropyl alcohol solution, and then all parts dried
before reassembly.22 These steps are also listed in the Littmann website on stethoscope cleaning.
However, there are no specific guidelines for practitioners on how to clean their stethoscopes in
between patients.
10
3. Material and Method
This section describes the type of study design that was selected, and the methods
involved required to answer the research questions. The design was selected to
assess the reduction in microbial load on the stethoscope diaphragm pre- and post-
cleaning with 70% alcohol swab(s), and to evaluate the stethoscope cleaning
further, along with the techniques in data collection and plan for data analysis.
This is a cross-sectional and descriptive study. Data collection will be done via
questionnaires, stethoscope imprinting samples pre- and post- cleaning with 70%
All medical students in their clinical years (Years 3,4,5) available in UniKL Royal
College of Medicine Perak (RCMP) at the time of and data collection. The data
collection will be done at the foyer of the main building and foyer of the academic
11
3.4. Sample Size, Sampling Method and Sampling Frame
students in clinical years for this study with a confidence level of 95% with an
anticipated 50% reduction in bacterial CFU after cleaning with 70% isopropyl
alcohol and confidence limits of +/- 5%. The anticipated reduction was set at 50%
medical students to participate in this study in which the inclusion and exclusion
criteria will be applied. The sample size is calculated using the following formula:
N = population size
z = z-score
e = margin of error
p = standard of deviation
● Researchers
12
● RCMP medical students who do not give consent
13
3.6. Variables Definition
1. Sociodemographic
If yes, how many times? Participants state how Before/after every use, at
Agents used for stethoscope Participants state type of Alcohol swab, Alcohol-
cleaning during typical agents used for stethoscope based hand disinfectant,
patient care day cleaning during typical Alcohol swab and alcohol-
Others
14
When was the last time you Participants state the last Never, <6 months ago, >6
cleaned
the stethoscope
How do you determine the Participants state how they Feel using hand, visual
by participants to clean
their stethoscopes
Timing Researchers observe how <2 secs, 2-5 secs, 5-10 secs,
alcohol swab(s)
15
Motion Researchers observe the Circular, side to side,
diaphragm
The data will be collected from the study population in UniKL RCMP from 15th May 2023
to 1st June 2023 via questionnaire, laboratory sampling techniques and observation
checklist.
6 researchers (4th year medical students) will be trained by university microbiologists on:
i. Imprinting stethoscope diaphragm onto culture medium. The culture medium used is
nutrient agar
iii. The correct technique of culture medium transportation to and fro the university’s
microbiology laboratory and the foyers of the main and academic buildings
16
Phase 2: Pre-testing
Before the commencement of the study, a trial run will be done by the researchers to
3 groups consisting of 2 researchers each are formed. The duo will be stationed at various
places at the foyer of the main and academic buildings and student lounge of UniKL
RCMP.
will explain accordingly using the study respondents’ information sheet, on the aim of the
study, assurance of confidentiality, benefits of the study for evaluation and data collection
identification (ID) number (eg. 001. 001, 003) for use in the questionnaire, checklist and
petri dishes.
17
B. Imprinting of stethoscope diaphragm onto nutrient agar (which is the culture
Researcher 2 will hold the stethoscope’s bell and imprint the stethoscope diaphragm
onto the nutrient agar labelled according to their unique ID number (e.g.: 001 A,
002A) while taking care to prevent the stethoscope’s stem and tubing from touching
the nutrient agar. The stethoscope is then returned to the respondent. Respondent
After the cleaning, the stethoscope will be passed to Researcher 2 again who will
then hold the stethoscope’s bell and imprint the cleaned stethoscope diaphragm
onto the nutrient agar labelled according to the unique ID number (e.g.: 001B, 002B)
while taking care to prevent the stethoscope’s stem and tubing from touching the
nutrient agar. This imprint is carried out at least 30 seconds after the cleaning of the
the study respondents using an observational checklist tool called ‘Checklist on the
After cleaning the stethoscope, Researcher 1 will then proceed to complete the
iii. All the samples collected on the culture medium will be transported back to the
university’s microbiology laboratory in a large storage container within the same day and
18
incubated for 24 hours. The next day, after incubation, colony counting and identification
of organisms will be done by the 6 researchers (4th year medical students). Colony
counting will be done using a colony counter in the university laboratory. Identification of
the microbes will be done on 70 culture medium (post-cleaning stethoscope samples) and
1. Master data collection form will have information of the medical student’s study
2. Patient information sheet and written consent form contain information on the aim
of the study, assurance of confidentiality, and benefits of the study (refer Appendix
B).
(Refer Appendix C)
This questionnaire will be used for evaluation and data collection purposes. It is
18-2023
19
The observation checklist developed and filled by the researchers will be used for
the number of alcohol swabs used, duration (in seconds), motion (using the alcohol
swabs), and parts of the stethoscope cleaning (to put in sequence if more than 1 part
is cleaned).
enter the data on reduction of microbial load on the stethoscope diaphragm surface
after cleaning with 70% isopropyl alcohol and also the data on the presence of
coagulase-positive samples
aureus (MRSA)
20
● 2 alcohol swabs (100s)
● 2 bunsen burners
● 2 parafilm
● 6 stopwatches
21
Figure 1: Methodology flow chart diagram
22
3.8. Ethical Consideration
Ethical clearance for the study will be obtained from the Medical Research and Ethics
Committee (MREC) of RCMP prior to conducting the study. The study will be conducted
after formal institutional approval is obtained from the dean of RCMP. Participation will
be voluntary and written consent will be obtained from each respondent. Participants can
Participants will not be given any forms of rewards or incentives for participating in the
study. Participants will be given access to their information pertaining to this study or they
All data collected and responses obtained from the questionnaire will be kept confidential
from any public domain and no identifiers collected. Password protected computers will
be used to store digitised data and data in papers will be stored in a locked cabinet. The
master data collection sheet containing the information of the respondents and samples will
be kept for a duration of 3 years after the study ends, and consequently destroyed afterwards
via paper shredding and complete wipe out from the researchers’ computer. The subject
the respondents. Each respondent is given a unique study ID number (eg: 001, 002) to aid
in data analysis.
23
4. Publication Policy
Results and data presented in the study report will not identify any individual participant. The
study data will be analysed collectively in groups. There will be no identifiable data available in
any publication or research finding presentations pertaining to this study. Approvals from relevant
authorities will be obtained prior to any presentation or publication of the data deriving from this
study.
All statistical analysis will be analysed using Statistical Package for the Social Sciences
(SPSS) build 1.0. 0.1275. Categorical variables will be analysed using Chi Square Test.
All categorical data including the stethoscope cleaning practices and the methods of
For the laboratory samples, the average percentage of reduction of colony-forming units
(CFU) is calculated using the formulae below, where n=67 (sample size):
24
Average percentage of reduction in CFU
CFU reduction of more than or equal to 50% will be categorised as ‘more sanitary
25
Commented [1]: Do we need?
5 Work Plan and Budget
Gantt Chart
Tasks : 1 2 3 4 1 2 3 4 1 2
X X
Brainstorming
research idea
X X
Objective
development
X X
Research
proposal
development
X X
Questionnaire
development
X X
Research
26
proposal
development
X X
Questionnaire
development
X
Proposal
presentation
X X
Proposal
improvement
for NMRR
registration
X
Proposal
submission for
MREC
approval
X
Pre-testing for
questionnaire
X X X X X
MREC
approval
27
X X X X X
Obtaining
permission
from relevant
authority for
use of venue
X X X
Data collection
X X
Data Analysis
X
Study report
preparation
28
Budget Commented [2]: Do we need?
form
-Questionnaire
-Observation checklist
-Proposal
Binding 2 sets 10
Stationeries - 20
Catalase 70 sets
Coagulase -
29
strips)
Mueller-Hinton agar 50
(MHA)
broth)
Bunsen burner 2
Parafilm 2
Total 1295
30
6 Results
Year 3 30 43
Year 4 27 39
Year 5 13 19
Table 2: Data on reduction of microbial load on the stethoscope diaphragm surface before
cleaning and in between examining patients by cleaning with 70% isopropyl alcohol
Sample CFU count (pre) CFU count (post) Reduction of CFU (%)
Yes 47 67
No 24 34
31
At least once a day 0 0
Every 1 to 4 weeks 22 31
Every 5 to 8 weeks 7 10
Others 4 6
When was the last time you removed the diaphragm and rim to be properly cleaned?
Never 31 44
Yes 34 49
No 14 20
Visual assessment 17 24
Others 0 0
32
Table 4: Data on Stethoscope Cleaning Methods (Observational Checklist)
1 64 91
2 4 6
More than 2 2 3
<2 10 14
2-5 18 26
5-10 21 30
>10 21 30
Circular 63 90
Side-to-side 6 9
Twisting 1 1
Others 0 0
Diaphragm 67 96
Rim 42 60
Bell 55 79
Tubing 28 40
Earpiece 33 47
33
Table 5: Difference in CFU percentage between academic years of medical students
1. Year 3
2. Year 4
3. Year 5
1. Circular
2. Side-to-side
3. Twisting
4. Others
34
7 References
6(3), 148–151.
4. Young IJB, Luz S, Lone N (2019) A systematic review of natural language processing for
classification tasks in the field of incident reporting and adverse event analysis,
https://doi.org/10.1016/j.ijmedinf.2019.103971
5. Waghorn, D., Wan, W.Y., Greaves, C.D., Whittome, N., Bosley, H., & Cantrill, S. (2005).
6. Ghumman, G. W., Ahmad, N., Pop-Vicas, A., & Iftikhar, S. (2018). Stethoscope cleaning
stethoscope cleaning practices: What we haven't learned in 150 years. Am J Infect Control.
35
8. United States. Littmann Stethoscopes. (n.d.). Retrieved March 6, 2023, from
https://www.littmann.com/3M/en_US/littmann-stethoscopes/my-stethoscope/using-your-
stethoscope/care/
nosocomial infection: analysis of 1,022 outbreaks. Infect Control Hosp Epidemiol 26: 357–
361.
11. World Health Organization. (2010) The burden of health care-associated infection
12. Bansal, A.; Sarath, R.S.; Bhan, B.D.; Gupta, K.; Purwar, S. (2019) To assess the
stethoscope cleaning practices, microbial load and efficacy of cleaning stethoscopes with
13. Bukharie, H.A.; Al-Zahrani, H.; Rubaish, A.M.; Abdulmohsen, M.F. (2004) Bacterial
14. O’Flaherty, N.; Fenelon, L. The stethoscope and healthcare-associated infection: A snake
15. Muniz, J.; Sethi, R.K.V.; Zaghi, J.; Ziniel, S.I.; Sandora, T.J. Predictors of stethoscope
disinfection among pediatric health care providers (2012 Am. J. Infect. Control: 40, 922–
925.
16. Gerken, Anne; Cavanagh, S.; Winner, H.I. (1972). Infection Hazard from Stethoscopes in
36
17. Peacock, W.F.; Kalra, S.; Vasudevan, R.S.; Torriani, F. (2021) Aseptic Stethoscope
Barriers Prevent C difficile Transmission In Vitro. Mayo Clin. Proc. Innov. Qual.: 5, 103–
108
18. Sengupta, S.; Sirkar, A.; Shivananda, P.G. (2000) Stethoscopes and nosocomial infection.
https://link.springer.com/article/10.1007/BF02723663?msclkid=2b88a55ad01711eca5ad4
19. Parmar, RC, Valvi, CC, Sira, P, et al. (2004) A prospective, randomised, double-blind
study of comparative efficacy of immediate versus daily cleaning of stethoscope using 66%
20. Nunez S, Moreno A, Green K, Villar J. (2000) The stethoscope in the emergency
10.1017/s0950268800003563
21. Mehta AK, Halvosa JS, Gould CV, Steinberg JP. (2010) Efficacy of alcohol-based hand
https://doi.org/10. 1086/655437.
22. Centers for Disease CaP. Guideline for disinfection and sterilisation in healthcare facilities.
2008.
23. Ghumman, G. W., Ahmad, N., Pop-Vicas, A., & Iftikhar, S. (2018). Stethoscope cleaning
37
8 Appendices
8.1 Appendix A
4. Introduction:
It is important that you understand why the research is being done and what it will involve. Please take your
time to read through and consider this information carefully before you decide if you are willing to
38
participate. Ask the study staff if anything is unclear or if you would like more information. After you are
properly satisfied that you understand this study, and that you wish to participate, you must sign this
Your participation in this study is voluntary. You do not have to be in this study if you do not want to. You
may also refuse to answer any questions you do not want to answer. If you volunteer to be in this study,
you may withdraw from it at any time. If you withdraw, any data collected from you up to your withdrawal
will still be used for the study. Your refusal to participate or withdrawal will not affect any medical or
This study has been approved by the Medical Research and Ethics Committee, RCMP
The purpose of this study is to determine the reduction of microbial load on the stethoscope’s diaphragm
surface pre- and in-between examining patients. This research is necessary to improve the understanding
of stethoscope hygiene.
This research will be conducted for a duration of 10 days (15/05/2023 till 24/05/2023). The expected
It is important that you answer all of the questions asked by the study staff honestly and completely which
39
You will be interviewed by any one of the researchers listed previously. The interview form contains 2
sections which will enquire about your sociodemographic data and stethoscope cleaning practices.
We will also imprint the diaphragm of your stethoscope onto a nutrient agar plate, before and after cleaning
with 70% isopropyl alcohol that will grow any potential microbes.
7. What are the potential risks and side effects of being in this study?
Participation in this study will not affect up in any ways, and the risk is minimal. You are free to decline to
There may or may not be any benefits to you. Information obtained from this study will help assess if there
This study does not receive any external funding. You will not be paid for participating in this study.
All your information obtained in this study will be kept and handled in a confidential manner, in accordance
with applicable laws and/or regulations. When publishing or presenting the study results, your identity will
not be revealed without your expressed consent. Individuals involved in this study, qualified monitors and
40
auditors, and governmental or regulatory authorities may inspect the study data, where appropriate and
necessary. Your personal information and study findings will be provided to you upon request.
If you have any questions about the study or if you think you have a study related injury and you want
information about this study, please contact the study researchers, Nandhini Palaniyappan at telephone
number 012-621 7045 or Amira Farzana Binti Mohamed Zaini at telephone number 019-657 0188.
If you have any questions about your rights as a participant in this study, please contact: The Secretary,
41
8.2 Appendix B
• I have been given oral and written information for the above study and have read and understood
• I have had sufficient time to consider participation in the study and have had the opportunity to ask
• I understand that my participation is voluntary and I can at any time free withdraw from the study
without giving a reason and this will in no way affect my future treatment. I am not taking part in any other
research study at this time. I understand the risks and benefits, and I freely give my informed consent to
participate under the conditions stated. I understand that I must follow the study doctor’s (investigator’s)
• I will receive a copy of this subject information/informed consent form signed and dated to bring
home.
Subject:
Signature: I/C number:
Name: Date:
Impartial witness:
Signature: I/C number:
Name: Date:
42
8.3 Appendix C
Respondents
ID: _______________________________
SOCIODEMOGRAPHIC DATA
a) Academic year
(1) Year 3
(2) Year 4
(3) Year 5
43
THIS SECTION IS ONLY FOR THOSE WHO ANSWERED ‘YES’ IN 2(B).
c) Agents used for stethoscope cleaning during typical patient care day?
d) When was the last time you removed the diaphragm and rim to be properly cleaned?
e) Do you wait for the stethoscope to dry after using the disinfectant?
_______________________________
(3) Wait for less than 30 seconds
44
8.4 Appendix D
METHOD OF CLEANING
3. Motion:
_________________________
(2) Side to side
(3) Twisting
(1) Diaphragm
(2) Rim
(3) Bell
(4) Tubing
(5) Earpiece
45
8.5 Appendix E
46
47